NIH says its 1-million-person health study is off to good start

A plan to entice 1 million people in the United States to volunteer for a huge study of health and genes is making good progress 1 year after its national launch, organizers said this week. The All of Us study run by the National Institutes of Health (NIH) in Bethesda, Maryland, has recruited 143,000 participants who have already taken surveys and visited a clinic to give blood and urine samples. Another 87,000 have at least registered for the study.

Study leaders say these numbers give them confidence All of Us will reach 1 million participants within 5 or 6 years—although they will need to ramp up enrollment to reach that goal. And they expect to broaden the study’s geographic distribution, which so far largely covers just a few states.

Announced by then-President Barack Obama 4 years ago, the All of Us study, which could cost $4 billion over 10 years, aims to enroll a diverse swath of U.S. inhabitants—citizens or not—who agree to share their health records and DNA on an anonymized basis. Researchers will use the data to develop “precision medicine,” or personalized treatments for others—the study participants themselves can request their genetic data but won’t receive medical help as part of the project. The 143,000 people who have given consent, taken surveys, and visited a clinic for physical measurements and to give blood and urine samples meet All of Us’s original diversity goal: Fifty-three percent are ethnic or racial minorities, far more than the 39% these groups constitute in the U.S. population. (For example, participants with self-identified African ancestry constitute 20% of the study, compared with 13% in the population.)

And 80% are from groups All of Us has defined as “underrepresented in biomedical research.” That includes gay people, rural dwellers, the elderly, and those who are disabled or don’t have good access to medical care. In just its first year, “All of Us has managed to become one of largest, most diverse research resources in history,” said NIH Director Francis Collins at a 6 May event marking the study’s anniversary.

The enrollment figures are not quite as rosy as they initially appear. For one thing, NIH had already enrolled 20% of the total before May 2018 during pilot testing. And some people who sign up online will never show up at a clinic to fully participate, says NIH’s Eric Dishman, director of All of Us. However, he expects enrollment to reach 4000 people a week by next fall—on track for 1 million within 6 years—as the study adds more sites. The pace will also pick up when the study eventually begins to enroll children.

To speed things up, Dishman’s staff members are tweaking the study’s original plans. For example, the health provider organizations (HPOs) enrolling many participants can now include people who don’t get health care through that HPO. And a pilot project will soon send 13,000 saliva kits to people who sign up online or by phone through the study’s “direct enrollment” process. Study staff can then quickly test these volunteers’ DNA for disease-associated markers, then later have them visit a clinic to give blood for fuller genome sequencing.

All of Us has also unveiled a “research hub” that holds pooled health and survey data for participants. (A “workbench” where approved researchers can work with the full data set will go online next winter.) The data show that more than two-thirds of fully enrolled participants come from just six states with participating HPOs, with 19% of participants from Arizona (which has 2% of the U.S. population). Dishman says Arizona surged ahead because it had effective “techniques and methods” for recruiting. Although the study won’t attempt to represent the U.S. population’s geographic diversity, the distribution will even out as more volunteers join the study via direct enrollment, which could end up including half of all participants, he says.

Overall, Dishman is not worried about reaching 1 million volunteers. “What I am worried about is retaining 1 million,” or keeping people from dropping out during the study’s 10-year span, he says. All of Us plans to work on that by holding community events in key cities to “gin up excitement about the program and pull people through,” he says.